FDA Panel Urges Stronger Warning on Antidepressants

Finally, like, a year later, the US Food and Drug Administration has come up with a recommendation regarding the use of antidepressant medication in children.  Two recommendations, actually.  Previous posts in this blog have documented the long strange trip it has been.  Years ago,  Hillary R. Clinton tried to get the FDA to mandate tougher testing requirements for pediatric medications.  There was all kinds of political flak, and it tooks years for anyhting to come of it.

Now, one year after the story about the possibility of antidepressant medication increasing the risk of suicide-related behavior in children, the FDA has made a clear statement, based upon careful analysis of the available data.  Although the data are limited, such that the most important questions still are not answered, at least we have enough clarity that doctors, parents, and patients can proceed with treatement decisions.  From the New York Times:

F.D.A. Panel Urges Stronger Warning on Antidepressants
September 15, 2004
By GARDINER HARRIS

BETHESDA, Md., Sept. 14 - Federal drug regulators should warn physicians and patients in the strongest possible terms that antidepressants not only cause some children and teenagers to become suicidal but most have also failed to cure their depression, a federal advisory committee voted Tuesday. [...]

"A black box is the strongest emphasis on warning information that we know how to do," said Dr. Robert Temple, director of the agency's office of medical policy.

After two days of testimony about the risks and benefits of the pills, the committee also agreed unanimously that the agency should require pharmaceutical manufacturers to attach a patient guide to the drugs' packaging that would describe the risks of suicide in plain language. Hundreds of approved drugs have black-box warnings, but fewer than 30 are required to have such patient attachments, F.D.A. officials said.

Also see this link  from FDAAdvisoryCommittee.com for more information. 

The patient attachment thing is a bit unusual.  This follows a finding, earlier this year, that a black box warning about the risk of QTc prolongation did little to change the prescribing behavior of physicians.  (See this link  for some background information on this and on the subject of black box labelling.  Note, though, that the article is not entirely accurate about some things.)  The use of an attachment that goes directly to the patient will reinforce the message. 

The complexity of the issue was illustrated by one of the committee members, who actually voted against the new requirements (from FDAAdvisoryCommittee.com):

The black box warning “won’t make prescribing [in children] more difficult,” Psychopharmacologic Drugs Advisory Committee Chair Wayne Goodman, MD, University of Florida McKnight Brain Institute, maintained. However, he added, “I anticipate there will be alarm from parents and the child.”

“I think that it is worth that complication because it will raise the threshold to prescribing and force an engagement of a discussion not only about the risk but the potential benefits and alternatives to medication,” Goodman said.

The committee members and consultants voted 15 to eight in favor of a black box warning.

Voting consultant Matthew Rudorfer, MD, National Institute of Mental Health, opposed the black box. “I believe that while we’re concerned about a 2%-3% increase of risk of suicidality, I think the underlying illness carries a 15% risk of suicide if left untreated and I fear that the black box will impede access to treatments,” he said.

“I think the appropriate warnings could be conveyed in bolded language that would more likely both be appreciated by prescribers without scaring off patients and families and clinicians,” Rudorfer added.

It will be interesting to see what popular and political responses arise from the latest FDA action.